Transcript: Medtronic MiniMed670G Trial Patient Les Hazelton on How This Device Changed His Life

Speaker 1: Thanks for tuning into the Diabetes Dish podcast brought to you by DiabeticLifestyle.com. Here's your host Maureen Connolly.

Maureen: So hi listeners Maureen Connolly here the host of the Diabetes Dish, a podcast from DiabeticLifestyle.com, a Vertical Health digital property.

So we've got a great show for you today. In fact I think it's fair to say that the topic we're going to tackle focuses on what people in the diabetes community would say is a history making event. On September 28th of this year, so 2016, the FDA approved what folks are calling the first hybrid artificial pancreas. The Medtronic MiniMed 670G. It's a device that's slated to be on the market in spring 2017.

And following the announcement the director of the FDA's center for devices, Jeffrey Shuren said this first of its kind technology can provide people with type one diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin. And so what makes this hybrid closed looped system unique is that in addition to checking glucose levels every five minutes, if glucose levels drop for instance, the device can deliver insulin and make adjustments that are customized to the user's needs. So essentially the system takes care of background insulin levels.

But for the record this device isn't technically an artificial pancreas because using the device still requires involvement from the user. You still have input it info about carbs and your blood glucose readings to calibrate the sensor. Plus the pump recommends an insulin dose and then the user pushes a button on the insulin pump to deliver the pre-meal bolus dose.

But all that said, the device is still a major game changer for people that's it's been approved for. Teens 14 and up and then adults. However the system is not approved for use in pregnant women and patients with impaired kidney function according to Medtronic.Les Hazelton of Minnetonka Minnesota has type one diabetes that was diagnosed 17 years ago when he was 43 and he was one of the participants in the Medtronic MiniMed patient trial along with 120 other teens and adults with type one diabetes. The trial took place at the International Diabetes Center at Park Nichollet Methodist Hospital in St. Louis Park Minnesota. Participants all wore the device for three months. A few of the outcomes reported, better blood sugar control, no DKA, no severe hypoglycemia, no serious device related adverse events. What's probably the most telling is that 99 of the original 123 studied participants including Hazelton opted to keep using the device after the trial ended.

So we reached out to Hazelton to see if he'd talk to us about the experience in the trial along with being a regular user of the Medtronic MiniMed. And I'm happy to welcome him to the show. Les so much for joining us.

Les Hazelton: Maureen thank you I appreciate you having me.

Maureen: Before we get into your experience in this trial and how your life has changed because of this device, I was hoping you could tell people listening a little bit about your diagnosis. Here you are 43 and fill us in. How did you discover that you had type one?

Les Hazelton: I'm somewhat of an avid bicyclist and I was on a week long bicycle trip and burning calories and carbs left and right and started losing some weight. When I get back from my bike trip I went in to see my GP just to make sure everything was okay and to my surprise not only did I have a high blood glucose but I had had diabetes for an indetermined amount of time. And with that high blood glucose I was losing weight rapidly and my hunger could not satisfy my body's needs to put the weight back on or control my blood sugars. It was quite a shock but a lifestyle change nonetheless that I was willing to make.

Maureen: To be clear, this was not a type two diagnosis, right? Type one?

Les Hazelton: I was immediately diagnosed with type one, yes.

Maureen: Did you have the thirst that so many people had as well? Or was it for you just that constant hunger?

Les Hazelton: It was constant hunger. I was exercising, biking six days a week and honestly I thought I had beat the midlife spread. Losing weight, I felt great and honestly I did not recognize the symptoms of diabetes until after I was diagnosed.

Maureen: You leave the office with what? Study up on diabetes and you have to give yourself insulin shots now. How did that all play out?

Les Hazelton: I immediately the very next day after my diagnosis started injecting insulin. Not only my fast acting but my background insulin as well. It was something that not even though it was a shock, there was something I could start on immediately to start controlling my blood sugars and getting better.

Maureen: And did you notice physical effects right away? Feeling better?

Les Hazelton: I did. Once I started injecting the symptoms that I didn't realize that I was having started disappearing. But through learning how to manage it came other problems and issues. Not counting carbs correctly, overdosing, under dosing so now that I was trying to take care of it, now there's other things that need to be top of mind on a daily basis.

Maureen: As far as your lifestyle, how did it impact? I know you have a big job, do you work for an advertising agency?

Les Hazelton: I do, I'm a creative director for an advertising agency, yes.

Maureen: During a typical work day how often would you say managing your diabetes was coming into play? Did you feel overwhelmed by it?

Les Hazelton: Yes having a hectic daily schedule sometimes didn't allow me to take my blood glucose. I sometimes had forgotten to do it before meals and double check a couple hours after meals. Doing injections it was kind of difficult to get into a routine that basically would have helped me.

Maureen: And so you kind of go along here, is it 17 years later?

Les Hazelton: Yes.

Maureen: That you just heard about this trial? And what, where did you hear about it? What prompted you to say yeah, I want in on this?

Les Hazelton: Well I started using a pump, a MiniMed pump about 10 years ago and I found that my management was much better. But kind of like injecting I was kind of what I call a yo-yoer. I would have extreme lows, extreme highs even though the pump would dispense the right amount of insulin that I needed pre and post meal. Again I was unaware of what my blood sugars were doing but my management was better. So about a year and a half ago my endocrinologist at Park Nicollet recommended that I apply to be part of this hybrid closed loop study and thankfully I was accepted in the first group of four to go through the trial.

Maureen: Excellent. And so you start using this device and tell me did you notice were there big differences within the first day of wearing the 670G?

Les Hazelton: The 670G is great and I joke when I talk to others including type one diabetics. Now from the very get go feel like I have a better relationship with my pump. It kind of is one of those things that it talks to you, you talk back to it and through that, the results were from the very first day. And the more I wore the pump and the more I got used to the regimen my blood sugars got better and better and better.

Maureen: That's really amazing. Can you talk a little bit about the features, maybe just to help educate people who might be interested in it 'cause there are a couple things that you can basically stop your insulin delivery for up to two hours I guess when the CGM sensor reaches a preset low. Is that something that you ...

Les Hazelton: There's many features and there's a couple things that I joke about being a nuisance. This relationship I have, it will give me an alert for several different situations. I have it set that when my sensor glucose drops below 70 it alerts me that I'm about to have a low. If it gets about 220 it will alert to me to say that I'm having a high. And it will tell me how fast or how rapid my drop or my rise is going. It will indicate a SG number on the screen and give me one arrow, two arrows or three arrows to tell me how rapidly. I'm aware of what my situation is better now because of those features and I can treat the situation much more quickly and don't find myself having too many hypo or hyper experiences.

Maureen: Do you find that you slept better because you weren't afraid of dying, people they fear, my gosh what if I don't wake up? It's a reality.

Les Hazelton: Exactly. The incidence of hypo events for me was mostly overnight and the fear of not feeling your body's blood glucose dropping that quickly, I think that the 670G does a great job, it gives me an alert, wakes me up, it wakes my spouse up and I can double check it and treat it right then and there. It's amazing.

Maureen: So your wife must be pretty happy about it as well. Knowing that ...

Les Hazelton: She's gone through this whole experience with me and I can't, you can't do it without the support and understanding of those people that you're closest to in your life. And having that it's kind of part of the success I believe I've had.

Maureen: That's great. And what one behavior do you feel like you've changed because of the pump and the information that your getting back? You know the feedback.

Les Hazelton: Well from a business lifestyle it's as I said, I kind of have some stressful or hectic days and if I don't get to checking my blood glucose either before a meal or after a meal, let's say I'm in an all morning meeting, at least I know where I am within the range that's set on my 670G and I can monitor that or I can turn the alarms off and it will vibrate at me and I'm still aware of how I'm doing and if I need to treat myself with an additional bolus or eat something to raise a hypo.

Maureen: That's great. Is this information sharable with other people? Is that one of the features or is that not part of? In other words could your spouse look at, kind of get a reading on your highs and lows?

Les Hazelton: It's available. The new color screen on the 670G is great. All I have to do is push the button on the front, I get a display, it tells me where my SG reading is at the moment for my CGM and I can even look at a graph that shows what my blood sugars or my SG readings have been for the last 12 hours. So I can even see during the day where I was peaking, where I was low and my goal is to keep it within the range that was set by the study group.

Maureen: So are you curious about certain foods? Having that slice of pizza or two, you see it right there and go, wow, I didn't realize, talk a little bit about food. Meals and how you maybe enjoy them more differently.

Les Hazelton: I've always kind of been very cautious about what I eat, I try very hard to have an accurate carb count but the pump still features square and dual boluses that my old pump had so you can kind of adjust for that based on what you're eating. I would say from an emotional level when having a meal I don't worry as much about what it is I'm eating. Especially like when you go out. A lot of times you go to a restaurant, you don't know what's in that salad dressing. You don't know how something is prepared and your carb count isn't the greatest. Having this feature on the new pump allows me to double check and it will tell me whether I'm going high or going low. There's a sense of support and ease when it comes to eating meals.

Maureen: Like someone's got your back.

Les Hazelton: Exactly.

Maureen: You mentioned earlier that you're an avid cyclist. When you ride where do you wear the pump? And I'm even more curious how the pump has changed your experience of biking?

Les Hazelton: There's a lot of different accessories that I've tried and they're all good but I still just clip it on the waistband of my biking shorts and ride on. But depending on what my ride is going to entail, some days I go out for a shorter ride, 10 to 15 miles. Some weekends I try to do 25 to 50. But the feature that I take advantage of most is the temp basal. You can set that temp basal to deliver half of your bolus up front to take care of what you're blood sugars are at the time and then it will slowly dispense it or dispense it over say two hours and give you an alert to say your two hours are up and make sure you double check your blood glucose.

I've had no incidents while riding my bike, whether it's a short ride or a long ride and it kind of gives me the confidence that I can go out and have a workout of any of length and not have the fear of having a hypoglycemic incident.

Maureen: Wow. Do you think about your diabetes differently now?

Les Hazelton: I do. The one thing that I think is most beneficial is we all work to have a cure as soon as possible and I hope it's in my lifetime but my experience has not only benefited me and I feel I have a better quality lifestyle being more in control of diabetes but this whole experience through the study and having it approved for consumer use I think has given some hope to those people who can't manage as well as they need to or even the juvenile diabetics who can have a better regiment at a younger age and even take the worry off of the parents or caregivers. I see that as one of the huge benefits of the new hybrid closed loop artificial pancreas. That's a big burden on parents of younger children.

Maureen: So guess that kind of ties in a little bit with this next question which is what advice would you have for people with diabetes regarding future technology for diabetes care? This is here do you feel like what's to come? Do you have a sense of ...

Les Hazelton: I don't know what's to come there are so many great studies that are out there. So many different ways that we can manage our disease. But I would encourage everyone who goes to their endocrinologist to help them put together a plan. I would look into the studies that are out there that may provide them with a solution. I'm fortunate to be part of the Park Nicollet in the International Diabetes Center and through my endocrinologist was made aware of this study that the research department was doing and I would encourage anyone, type one or type two to make sure that they talk to their endocrinologist to see what's available to experience.

Maureen: And just a note that I read Medtronic is actually recruiting pediatric patients right now, ages seven to 13 for a trial. Anybody listening if you can go to clinicaltrials.gov to get more information or actually visit DiabeticLifestyle.com and we'll include the info on how to get more info from them in our highlight notes that we post from this podcast.

The one thing we didn't touch on is the price. There doesn't appear to be a set price just yet but I know just based on what the other Medtronic models average about, you're looking at about in the neighborhood, maybe $799. And again we're not saying that that's the price but so I guess people are able to trade in older models for a nice little rebate, but what do you think about the cost prohibitiveness of, for some people?

Les Hazelton: It's an important step when considering going to a pump therapy. I'm kind of unaware of where the price of the new 670G is going to land. But there are also many different ways to help supplement whether it's individual health care insurance, the study group I would encourage everybody if they're thinking about it to look into ways to help them be able to manage the financial side of it as well. I'm again fortunate but it has all worked out for me and whatever I have been contributing to make this part of my diabetes management has reaped more benefits than I could ever say.

Maureen: That's excellent. And just today I actually read a statement from Louis Dias who's the chief patient office at Medtronic Diabetes and he says that if you want to be first in line to receive the new system you can check out the priority access program. I guess if you just go to MedtronicDiabetes.com and they say anyone who purchases a MiniMed 630G system between this past August and when they ship the MiniMed 670G will be eligible to upgrade to the new system for just 299. And in addition if you want to take advantage of your year end insurance benefits you can buy the MiniMed 630G system between now and December 31 and you'll pay zero dollars to upgrade provided you participate in an approved system access program where restrictions may apply. So I think that's kind of cool for people to know about.

One last question, I didn't ask about your endocrinologist. Has this feedback been really useful for him or her in terms of how it seems like you have your treatment under control, the management but did you find that interesting or did he have anything to weigh in on about it?

Les Hazelton: Well during the study we had to one chief endocrinologist if you will who is dedicated at Park Nicollet in the research department and he was amazing. I go through a separate regiment to keep everybody on board, I upload the data from my blood glucose meter and my pump weekly so that that can be reviewed and I there are any changes, any issues that need to be addressed I get a phone call or I stop in and we make those adjustments. Once I get out of the first part of the study before I was asked to participate in the extended portion of the study I then met with my endocrinologist that I was meeting with prior to the study. The one who recommended that I get involved and she was amazed. I was able to share some of the data and information especially my amazing HbA1C and it's a great experience to know that your endocrinologist is supporting you and that the results have been so positive.

Maureen: That's great. So what was the difference? I'm just curious with the A1C? Noticeably?

Les Hazelton: I dropped 1.1 points. I went from 7.6 to a 6.5.

Maureen: Well done.

Les Hazelton: Thank you.

Maureen: Thanks again Les for taking the time to share your story. We'll check back with you 'cause I want to hear how you're doing six months, a year from now. I'm sure our readers are curious and listeners about how it's all working out. And if you want more information you can go to DiabeticLifestyle.com and thanks again and I guess we'll talk soon.

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